Inotrem has received approval from the French and Belgian regulatory authorities to perform clinical development of its therapy, nangibotide, up to registration in Covid-19 patients.
Nangibotide contains the active ingredient LR12, a 12 amino-acid peptide made by chemical synthesis.
LR12 is a selective TREM-1 inhibitor that works as a decoy receptor and hinders the TREM-1 and its ligand’s binding.
Nangibotide was demonstrated to rebuild necessary inflammatory response, vascular function, and enhanced survival rate, in preclinical septic shock models in animals.
As part of the latest programme, Inotrem will get $53m (€45m) in additional public funding under the ‘Capacity Building’ Call for Expression of Interest organised by the French national investment bank Bpifrance, on behalf of the country’s government.
This funding will support Inotrem’s clinical programme, which includes the randomised, double-blind, placebo-controlled, confirmatory, adaptive Phase II/III ESSENTIAL trial.
The ESSENTIAL trial will analyse the efficacy and safety of nangibotide for the treatment of severe Covid-19 patients with respiratory distress.
Assessment of nangibotide’s impact on disease progression in Covid-19 patients on ventilatory support and on respiratory failure severity, time on mechanical ventilation, length of intensive care stay, and death will be the trial’s primary goal.
In the initial stage, the trial will enrol up to 730 subjects at 40 trial centres in France and Belgium and could be expanded to other European countries.
The ESSENTIAL trial is an extension of a Phase IIa study, which assessed the safety and efficacy of nangibotide in 60 severe Covid-19 patients.
Inotrem co-founder and Scientific and Medical Affairs executive vice-president and head Jean-Jacques Garaud said: “Nangibotide is a TREM-1 inhibitor, which has already demonstrated a trend towards efficacy in septic shock patients and has the potential to modulate the dysregulated immune response in critically ill Covid-19 patients.
“With this large clinical study, we can demonstrate efficacy for nangibotide in a further indication with the goals of reducing the duration of hospitalisation and mortality.”
In another development, Aridis Pharmaceuticals has reported that its Covid-19 monoclonal antibody cocktail, AR-712, attaches to and efficiently neutralises the Delta variant of the SARS-CoV-2 virus.
AR-712 is intended to be administered as an inhaled therapy at home for Covid-19 patients who are not in the hospital.